FDA 510(k)

CLUNGENE 藥物濟用試劑盒；CLUNGENE 藥物測試劑盒

K 號：K242802 · 2024-11-08

決定日期2024-11-08

產品代碼NGL

諮詢委員會此醫療器材法規描述涉及FDA、510(k)、PMA、NCT、PMID及相關網址，以下為繁體中文翻譯：本醫療器材之監管狀態係依據美國食品藥物管理局（FDA）之相關規定，包括510(k)上市前通知及PMA上市前核准程序。相關臨床試驗資訊可參閱NCT編號及PMID文獻編號，詳細資料請見所附網址。

決定相當於

器材摘要

CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-11-08 under 510(k) number K242802. The device is classified under product code NGL. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette?

CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette is a medical device that received FDA 510(k) clearance on 2024-11-08. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. The 510(k) number is K242802.

When did CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette receive FDA 510(k) clearance?

CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette received FDA 510(k) clearance on 2024-11-08, under 510(k) number K242802.

Who is the listed applicant for CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette?

The FDA 510(k) record lists Hangzhou Clongene Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette?

The FDA product code for CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette is NGL.

其他以 Hangzhou Clongene Biotech Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253318Clungene RSV 抗原快速檢測 K252118CLUNGENE 多藥檢測易杯；CLUNGENE 多藥家用檢測易杯 K193132CLUNGENE HCG懷孕快速測試儀盒，CLUNGENE HCG懷孕快速測試條，CLUNGENE HCG懷孕快速測試中間流 K190412CLUNGENE 多藥檢測濾卡，CLUNGENE 多藥檢測易杯 K181790CLUNGENE 多藥檢測濾卡，CLUNGENE 多藥檢測易杯 K180255CLUNGENE 多藥檢測濾卡，CLUNGENE 多藥檢測易杯

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相關器械（代碼：NGL）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K253567Healgen精準尿液藥物檢測濾卡；Healgen精準家庭尿液藥物檢測濾卡Healgen Scientific,, LLC K250803Deepblue 多藥尿液檢測杯；Deepblue 家用多藥尿液檢測杯Anhui Deepblue Medical Technological Co., Ltd.K250067Dochek® 多藥尿液檢測杯；Dochek® 多藥尿液檢測杯 ProGuangzhou Decheng Biotechnology Co., Ltd.K242428Dochek® 藥物濾尿試紙，Dochek® 藥物濾尿試紙加強版，Dochek® 藥物濾尿試卡，Dochek® 藥物濾尿試卡加強版，Dochek® 藥物濾尿試杯以及Dochek® 藥物濾尿試杯加強版Guangzhou Decheng Biotechnology Co., Ltd.K243365Healgen精準多藥尿液檢測杯；Healgen精準家庭多藥尿液檢測杯Healgen Scientific,, LLC K243064ETERBIO 藥物濃度快速檢測儀（膠體金）；ETERBIO 藥物濃度家庭檢測套件Eterbio, Inc.

官方來源

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